PMA P050044S016

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S016
Product code: LMF
Decision date: 2011-02-04
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR AN ADDITIONAL IN- PROCESS INSPECTION OF THE TRANSFER SYRINGES TO VISUALLY CHECK THAT THE CAPS ARE PRESENT AND APPROPRIATELY TIGHTENED.

Current openFDA PMA Record#

Device: VITAGEL SURGICAL HEMOSTAT
Applicant: Stryker Corp.
PMA number: P050044
Supplement: S016
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2011-02-04
Decision code: APPR
Date received: 2011-01-18
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ADDITIONAL IN- PROCESS INSPECTION OF THE TRANSFER SYRINGES TO VISUALLY CHECK THAT THE CAPS ARE PRESENT AND APPROPRIATELY TIGHTENED.